Department of Health and Social Care

Correction to Written Parliamentary Questions

Lord Markham: I would like to amend a written answer that I gave to the House on 26 March.An incorrect figure was provided in my reply to HL3163, which was asked by Lord Alton.For the MHRA, the PQ requested the number of Yellow Card reports received for Mirtazapine each year from 2014 to the present for sexual dysfunction and persistent sexual dysfunction.The reply stated that the MHRA has received a total of 46 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine, 4 of which include information that suggest the suspected adverse reactions persisted after mirtazapine was withdrawn. The data was also presented in a table by year.However, it has since been brought to my attention that the column in this table regarding Yellow Card reports of persistent sexual dysfunction should not have been provided in this format.I am informed by the MHRA, that the specific term ‘persistent sexual dysfunction’ does not represent a specific medical condition, so that this precise term is not a category available to undertake a structured search of the MHRA’s Adverse Drug Reaction database.The column of the original table labelled ‘Reports of sexual dysfunction that continued after Mirtazapine was withdrawn’ was provided using a search of additional structured data fields but it is now clear that this approach was not sufficiently comprehensive to provide an accurate answer on this point. I am assured that the information provided was not incorrect in the context of the limitations of the search, but it does not provide a sufficiently accurate overview of the situation.In order to provide this data a manual review of all the relevant reports would need to be undertaken to ascertain if the report concerns persistent sexual dysfunction. This would not be possible to do given the disproportionate resources required for colleagues to complete this for a Parliamentary Answer.The MHRA have reassured me that the number of Yellow Card reports of sexual dysfunction related reactions suspected to be associated with mirtazapine between 1 January 2014 and 11 March 2024 which was provided in the second column titled ‘Reports of sexual dysfunction’, and the total figure of 46 is correct and has not changed.The MHRA has therefore provided the following table as the corrected answer.YearReports of sexual dysfunction20143201512016220173201812019520203202152022102023920244Source: data provided by the MHRA.It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, are known.I would also like to amend a written answer that I gave to the House on 19 April 2024.The answer to questions HL3805, HL3806, HL3807 and HL3808, tabled by The Lord Bishop of St Albans, stated that “The recently announced TRANSFORM trial aims to find the best way to screen for prostate cancer. This study is led by Prostate Cancer UK and supported by £42 million of Government funding.”It has been brought to my attention by Prostate Cancer UK that the answer provided inadvertently overstates the amount of Government funding for the trial. In fact, the Government is providing £16 million out of the total £42 million cost of the trial, with the rest of the cost being met by Prostate Cancer UK and their supporters.I would like to apologise to the House for these errors and to reassure the House that both the Department and I take its responsibility for parliamentary accountability very seriously and steps have been put in place to ensure the accuracy of written answers in the future.

Home Office

State Threat Prevention and Investigation Measures (STPIMs) (20 December 2023 to 19 March 2024)

Lord Sharpe of Epsom: My rt hon Friend the Minister of State for Security (Tom Tugendhat) has today made the following Written Ministerial Statement:Section 55(1) of the National Security (NS) Act 2023 (the Act) requires the Secretary of State to report to Parliament as soon as reasonably practicable after the end of every relevant three-month period on the exercise of their STPIM powers under the Act during that period. STPIMs were introduced through the NS Act 2023 and came into force on 20 December 2023. There have been no STPIM cases during this first reporting period.